Repetitive Intestinal Lavage Using Polyethylene Glycol Solution in Patients With EHEC O104:H4 Infection During the German 2011 Outbreak for Prevention of Severe Thrombocytopenia With Subsequently Following Therapeutic Plasmapheresis

Study of Repetitive Intestinal Lavage in Patients With EHEC Associated Hemorrhagic Colitis

Sponsors

Lead sponsor: Universitätsklinikum Hamburg-Eppendorf

Source Universitätsklinikum Hamburg-Eppendorf
Brief Summary

The investigators examined the outcome of patients with severe Enterohaemorrhagic E. Coli (EHEC) O104:H4 infection suffering from bloody diarrhoea that were at risk to develop hemolytic uremic syndrome and underwent repetitive whole bowl lavage during hospitalization.

Detailed Description

During the 2011 German EHEC O104:H4 outbreak, centered in the area of Hamburg, 33 patients with EHEC associated hemorrhagic colitis were admitted to the first Department of Medicine of the Hamburg University medical centre.

The first 12 patients were treated symptomatically and received intravenous rehydration up to three liters daily.

Prompted by a good clinical response after whole bowel irrigation with polyethylene glycol-solution (PEG)in patient 13 all subsequent admitted patients (n=21) were treated with PEG-solution ( 2 liters on admission followed by one liter per day during the clinical course).

During the hospital course blood work was obtained every day and patients were examined for clinical symptoms.

Thrombocytopenia below 100.000/microliter was defined as a threshold for initiating therapeutic plasmapheresis to prevent the onset of hemolytic syndrome on an early stage.

Overall Status Completed
Start Date May 2011
Completion Date February 2012
Primary Completion Date June 2011
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Thrombocytopenia (Defined as platlet count below 100.000/microliter) Patients will be followed for the duration of hospital stay, an expected average of two weeks
Secondary Outcome
Measure Time Frame
Duration of hospitalisation Patients will be followed for the duration of hospital stay, an expected average of two weeks
Enrollment 33
Condition
Intervention

Intervention type: Drug

Intervention name: polyethylene glycol solution for daily bowel lavage.

Description: At admission,patients with severe EHEC infection received two liters of orally administered electrolytes- balanced polyethylene glycol solution for bowel lavage. Treatment was continued with one liter of polyethylene glycol solution daily for repetitive intestinal lavage during the clinical course.

Arm group label: PEG-Solution, daily bowel lavage

Other name: Klean-Prep(Norgine GmBH, Marburg, Germany).

Eligibility

Criteria:

Inclusion Criteria:

- Proven EHEC O104:H4-infection

Presence of bloody diarrhoea + at least one of the following serological criteria:

- platelet count below 150x10³/ μl but greater than 100x10³/ μl, serum creatine above normal level for age (> 1.1 -1.3 mg/dl), Lactate dehydrogenase (LDH) > 300 IU/l, leukocytosis ( > 12x10³/ μl ) and elevated CRP (> 5mg/l), hemoglobin < 13.8 g/dL for male patients or < 12.1 g/dL for female patients, respectively or decrease in haptoglobin

Exclusion Criteria:

- Bloody diarrhoea due to others reasons than EHEC O104:H4 infection

- Thrombocytopenia < 100x10³/ μl.

- HUS, defined as platelet count below 100x10³/ μl, anaemia or decrease in haptoglobin and serum creatine above normal level for age

Gender: All

Minimum age: N/A

Maximum age: N/A

Healthy volunteers: No

Overall Official
Location
facility 1Department of Medicine, University Medical Centre Hamburg-Eppendorf, Hamburg
Location Countries

Germany

Verification Date

March 2012

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: SOC-treatment

Arm group type: No Intervention

Description: Patients with EHEC associated bloody diarrhoea (n=12) receiving standard of care treatment, consisting of intravenous fluids (2-3 liters/daily), analgetics, including paracetamol and metamizol and metoclopramid, if required.

Arm group label: PEG-Solution, daily bowel lavage

Arm group type: Experimental

Description: Patients with EHEC associated bloody diarrhoea (n=21)receiving SOC-treatment, consisting of i.v. fluids (2-3 liter/day), analgetics ( paracetamol and metamizol) or metoclopramid and orally administered polyethylene glycol-solution daily during the clinical course.

Acronym EHEC-PEG
Study Design Info

Allocation: Non-Randomized

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov